Kazakhstan pharma serialisation framework goes live

As of today, all medicines imported into Kazakhstan or produced in the domestic market should be labelled with a serialised datamatrix code, part of a drive to protect patients from falsified medicines.

Kazakhstan’s model generally follows the system set up by Russia and aims to eventually achieve full traceability for medicines – including prescription and over-the-counter drugs – across the supply chain, and is broadly in line with other Eurasian Economic Area (EUAE) schemes that are rolling out.

From today (July 1), mandatory traceability comes into effect by law for all medicinal products, with medical devices and food additives set to follow in future.

That has been preceded by weeks of uncertainty about the status of non-serialised product manufactured before July 1 – in other words, whether it could be introduced into the market after that date. Last week, it was confirmed that non-serialised stock could be supplied to the market.

Like Russia, Kazakhstan’s model includes a cryptographic element provided by a centralised authority (Kazakh Telekom ) at a nominal cost each – known as a cryptocode – to go along with the serialised code and allow online as well as offline authentication.

The serialisation code is aligned to GS1 standards, as is the case with most other pharma serialisation initiatives worldwide, although the cryptocode element makes the full code longer. The codes can be printed directly onto the secondary packaging or applied as a sticker ahead of customs clearance.

The system involves calls for all stakeholders in the medicines supply chain to participate in a “complex reporting choreography,” according to Christoph Krähenbühl, senior director of Excellis Europe, which provides help and support on compliance with pharma serialisation and traceability requirements.

“Challenges that pharma companies have faced in this market include significant uncertainty about the compliance dates, in particular with regards to importing non-serialised drugs manufactured before today (with the grace period only finally confirmed last week), and - frankly - confusing messaging about how and where foreign manufacturers should register to gain access,” he told SecuringIndustry.com.

“Given this context, it would not be surprising to see some teething problems and further challenges to emerge as stakeholders ramp up their operations and scanning of medicines – including by patients using the official smartphone apps – starts in earnest.”

Falsified medicines are estimated to account for around 10 per cent of the total market in Kazakhstan, and the Ministry of Health has said that the mandatory labelling and traceability programme aims to eradicate the illegal trade in medicines, including grey imports.

Photo by engin akyurt on Unsplash